EVO101 Cream for Hidradenitis Suppurativa
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase < 1
Recruiting
Sponsor: Virginia Clinical Research, Inc.
Must not be taking: Biologics, JAK inhibitors
Disqualifiers: Severe HS, Pregnancy, Alcohol abuse, others
No Placebo Group
Trial Summary
What is the purpose of this trial?
The goal of this clinical trial is to learn if drug EVO101 works to treat mild to moderate hidradenitis suppurativa in adults. The main questions it aims to answer are: Does drug EVO101 lower the total number of lesion a participant has from the first visit to the last visit. What medical problems do participants have when applying drug EVO101 Does a participant perceive a change in their hidradenitis suppurativa symptoms based on patient reported outcome questionnaires. Participants will: Apply EVO101 topical cream 0.1% topically Visit the clinic four times unless the first and second appointment have to be done separately then there will be five clinic visits and one phone call over a twelve week period. Keep a dosing diary
Will I have to stop taking my current medications?
You may need to stop certain medications before joining the trial. Specifically, you cannot use antibiotics, certain topical treatments, or systemic therapies for hidradenitis suppurativa during the study. Some medications require a 'washout' period (time without taking them) before starting the trial.
How is the drug EVO101 Cream unique for treating Hidradenitis Suppurativa?
EVO101 Cream is unique because it may incorporate a novel combination of ingredients, such as hyaluronic acid and bacterial-wall-derived glycoproteins, which have shown effectiveness in rebalancing skin microbiota and reducing symptoms in other skin conditions like seborrheic dermatitis. This approach could offer a new mechanism of action compared to traditional treatments for Hidradenitis Suppurativa.12345
Eligibility Criteria
Adults with mild to moderate hidradenitis suppurativa, a skin condition that causes small, painful lumps under the skin. Participants must be willing to apply a topical cream, visit the clinic up to five times, and keep a dosing diary over twelve weeks.Inclusion Criteria
For women of childbearing potential: agree to remain abstinent or use a highly effective contraceptive method during the treatment period and for at least 30 days after the last application of study drug
I am 18 years old or older.
I have been diagnosed with hidradenitis suppurativa for at least 3 months.
See 6 more
Exclusion Criteria
I am not pregnant or breastfeeding.
I haven't taken certain medications or treatments recently.
Very severe, severe, minimal, or clear HS-PGA
See 4 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants apply EVO101 topical cream 0.1% and visit the clinic four to five times over a twelve-week period
12 weeks
4-5 visits (in-person), 1 phone call
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Treatment Details
Interventions
- EVO101 (Topoisomerase I Inhibitor)
Trial OverviewThe trial is testing EVO101 topical cream (0.1%) for treating hidradenitis suppurativa. It aims to see if this treatment reduces the number of lesions from first to last visit and improves symptoms based on patient questionnaires.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Open label EVO101 topical cream 0.1%Experimental Treatment1 Intervention
All eligible subjects will receive open label EVO101 topical cream 0.1%
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Virginia Clinical Research, Inc.Norfolk, VA
Loading ...
Who Is Running the Clinical Trial?
Virginia Clinical Research, Inc.Lead Sponsor
Evommune, Inc.Industry Sponsor
References
Clinical comparison of alclometasone dipropionate cream 0.05% with hydrocortisone butyrate cream 0.1% in the treatment of atopic dermatitis in children. [2017]Alclometasone dipropionate cream 0.05% was compared to hydrocortisone butyrate cream 0.1% in the treatment of atopic dermatitis in forty children, 5 to 11 years old. In this double-blind, parallel-group trial, the experimental creams were applied twice daily for 2 weeks, without occlusion, to the study areas. Efficacy was evaluated 1 and 2 weeks after the start of treatment. Both creams were effective treatments for atopic dermatitis; however, alclometasone dipropionate was judged slightly more efficacious. Improvement in erythema, induration, and pruritus averaged 76% for alclometasone dipropionate-treated patients and 70% for hydrocortisone butyrate-treated patients. At the end of treatment, the physician's global evaluation indicated nineteen of twenty patients in the alclometasone dipropionate group had between 51% and 100% improvement in disease signs and symptoms, compared with sixteen of twenty patients treated with hydrocortisone butyrate. Two patients in the alclometasone dipropionate-treated group and one in the hydrocortisone butyrate-treated group reported mild stinging.
Effects of a cream containing 5% hyaluronic acid mixed with a bacterial-wall-derived glycoprotein, glycyrretinic acid, piroctone olamine and climbazole on signs, symptoms and skin bacterial microbiota in subjects with seborrheic dermatitis of the face. [2020]Objective: A new cream formulation containing hyaluronic acid 5%, complexed with a mix of a bacterial-wall-derived glycoprotein and peptide glycan complex (EDS), has been recently developed. We evaluated in a prospective, assessor-blinded, 6-week study the efficacy and tolerability of EDS in the treatment of facial seborrheic dermatitis (SD) and the effects on skin microbiota. Subjects and methods: Seventy-five subjects (mean age 46; 60 men) with moderate-severe SD of the face were enrolled. EDS cream was applied twice daily. The primary outcome was the evolution of the Investigator Global Assessment (IGA) score, evaluating erythema, scale/flaking, grade of seborrhea and itch. Superficial skin bacterial microbiome at baseline and after treatment was assessed, using the 16S rRNA gene methodology, in affected and non-affected face areas. Local tolerability was evaluated checking self-reported side effects at each visit. Results: Baseline IGA scores (mean±SD) was 10±3. The use of EDS reduced IGA score significantly by 70% at week 3 and by 88% at week 6. An increase in the abundance of Cutibacterium acnes genera associated with a significant drop of Staphylococcus genera presence was detected in affected areas. The ratio of relative abundance of genera Cutibacterium/Staphylococcus increased significantly after treatment in affected areas. The product was very well tolerated. Conclusion: Treatment with EDS applied twice daily for 6 consecutive weeks was associated with a reduction of the signs and symptoms of SD. Furthermore, after EDS cream treatment, a reequilibrating effect on facial skin microbiota was observed. The product was very well tolerated.
Efficacy and patient-reported outcomes of a new mometasone cream treating atopic eczema. [2015]This double-blind controlled phase II study was conducted to compare a newly developed formulation of mometasone furoate with a water content of 33% (Monovo® Cream) and with a smooth consistency versus the commercially available fatty cream of mometasone furoate (Ecural® Fettcreme) in terms of efficacy, cosmetic properties, and patients' acceptance. In 20 patients with mild to moderate atopic eczema, the preparations were tested intraindividually in a randomized mode and in two comparable lesion areas. Both preparations were equally effective and well tolerated. Due to improved cosmetic properties, the new formulation was preferred by the patients when asked for preferential use. Quality of life could be improved by treating with both preparations.
Mometasone furoate-loaded aspasomal gel for topical treatment of psoriasis: formulation, optimization, in vitro and in vivo performance. [2022]Present investigation was aimed to develop aspasomal gel of Mometasone Furoate for the treatment of Psoriasis that are biologically active and deliver drug at controlled rate and decrease dosing frequency.
SCH 370 (clotrimazole-betamethasone dipropionate) cream in patients with tinea cruris or tinea corporis. [2014]The safety and efficacy of SCH 370 (1 percent clotrimazole/0.05 percent betamethasone dipropionate) cream was compared with each of its individual components in 331 patients with tinea cruris or tinea corporis. The study was a multicentered, randomized, double-blind, parallel-groups design. The patients received one of three treatments applied twice a day for two weeks and returned for a follow-up visit two weeks after the last application. Total signs and symptoms scores of infections were evaluated at baseline, once between days three to five, and after weeks one, two, and four. Culture and potassium hydroxide preparations were done at baseline and weeks two and four. SCH 370 cream demonstrated more rapid therapeutic activity than the antifungal agent alone, resulting in significantly better clinical results in early treatment and in midtreatment. As expected with a steroid, betamethasone dipropionate achieved relief of inflammatory signs and symptoms early in the course of treatment, but SCH 370 was superior from one week on in the patients with tinea cruris and at post-treatment in the patients with tinea corporis. Mycologically, SCH 370 cream and clotrimazole were comparable at the end of the study and results were significantly better than those for betamethasone dipropionate. All three treatments were safe with no reports of unexpected or serious adverse experiences.